Apparatuses and method for fixation of ankle syndesmosis or acromioclavicular joint dislocations of the shoulder

ABSTRACT

An apparatus for performing ankle syndesmosis repairs includes, inter alia, a first button, a second button, and a suture connecting the first button and the second button. The first button and the second button are stainless steel buttons. At least one of the first button and the second button is oblong. The suture includes multiple strands that extend between the first button and the second button. A first free end of the suture is tensionable to shorten a length of the suture between the first button and the second button and thereby move the first button and the second button closer together.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. application Ser. No. 16/542,565, filed onAug. 16, 2019, which is a continuation of U.S. application Ser. No.15/483,338, filed on Apr. 10, 2017, now U.S. Pat. No. 10,390,816, whichis a continuation of U.S. application Ser. No. 14/933,269, filed on Nov.5, 2015, now U.S. Pat. No. 10,206,670, which is a continuation of U.S.application Ser. No. 13/970,269, filed Aug. 19, 2013, which is adivisional of U.S. application Ser. No. 11/482,038, filed Jul. 7, 2006,now U.S. Pat. No. 8,512,376, which claims the benefit of U.S.Provisional Application No. 60/697,125 filed on Jul. 7, 2005, and whichis a continuation-in-part of U.S. application Ser. No. 10/233,122, filedAug. 30, 2002, now U.S. Pat. No. 7,235,091, which claims priority under35 U.S.C. § 119 to IE S2002/0504, filed Jun. 20, 2002.

The entire disclosures of all of the above priority applications areincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to an apparatus and a method for fixationof ankle syndesmosis.

BACKGROUND OF THE INVENTION

Ankle syndesmosis disruptions are usually caused by severe externalrotation ankle injuries. Surgery is recommended to reduce and internallyfix the diastasis to prevent lateral talar shift, which could otherwiselead to post-traumatic arthrosis. Such surgical treatment usuallyinvolves tibio-fibular transfixation using a syndesmosis screw asrecommended by the A.O. group (Arbeitsgemeinschaft fürOsteosynthesefrage (Association for the Study of Internal Fixation)).Disadvantages of syndesmosis screw fixation include the need for asecond operation for implant removal; implant fatigue and breakage; andloss of diastasis reduction following implant removal. Furthermore,prolonged non-weight bearing to avoid implant breakage prior to removalmay cause further morbidity. In addition, studies have shown ligamenthealing to be inhibited by full immobilisation.

Movement of the distal fibula relative to the tibia is seen in normalankle motion. Rigid fixation of the ankle syndesmosis, therefore,prevents normal physiological movement, until the rigid fixation deviceis removed, loosens or breaks.

Various methods of syndesmosis fixation have been studied before,including bioabsorbable implants (Thordarson D B, Hedman T P, Gross D,Magre G. “Biomechanical evaluation of polylactide absorbable screws usedfor syndesmosis injury repair” Foot Ankle Int 1997; 18: 622-7) andflexible implants (Miller R S, Weinhold P S, Dahners L E. “Comparison oftricortical screw fixation versus a modified suture construct forfixation of ankle syndesmosis injury: a biomechanical study” J OrthopTrauma 1999; 13: 39-42; Seitz W H Jr, Bachner E J, Abram L J, Postak P,Polando G, Brooks D B, Greenwald A S. “Repair of the tibiofibularsyndesmosis with a flexible implant” J Orthop Trauma 1991; 5: 78-82).Seitz used a suture-button fixation using a large polyethylene button,as is commonly used for tendon repair pull-out sutures and a No. 5braided polyester suture. Seitz's operative technique involved openingboth the medial and lateral sides of the ankle. On biomechanicaltesting, failure occurred through the polyethylene button at an averageof 20 kg of tension, and through the suture at 28 kg. Clinical testingin 12 patients showed good results, one patient having a symptomaticmedial button. Buttons were routinely removed at 8 to 12 months, andwere all found to be intact. Miller compared a modified suture constructagainst tricortical screw fixation at 2 cm and 5 cm above the anklemortise. This method also required opening both the medial and lateralsides of the ankle. No. 5 braided polyester suture was looped throughtwo holes drilled across the distal tibia and fibula. Similar resultswere seen for the suture and screw fixations, with a better holdingstrength for both groups at 5 cm.

It is an object of the present invention to overcome the problemsassociated with the prior art, whilst permitting normal physiologicalmovement of the fibula relative to the tibia.

SUMMARY OF THE INVENTION

An apparatus for performing ankle syndesmosis repairs according to anexemplary aspect of the present disclosure includes, inter alia, a firstbutton, a second button, and a suture connecting the first button andthe second button. The first button and the second button are stainlesssteel buttons. At least one of the first button and the second button isoblong. The suture includes multiple strands that extend between thefirst button and the second button. A first free end of the suture istensionable to shorten a length of the suture between the first buttonand the second button and thereby move the first button and the secondbutton closer together.

In a further non-limiting embodiment of the foregoing apparatus, thesuture is a braided polyethylene suture.

In a further non-limiting embodiment of either of the foregoingapparatuses, the suture is non-absorbable.

In a further non-limiting embodiment of any of the foregoingapparatuses, the suture is double looped through the first button andthe second button.

In a further non-limiting embodiment of any of the foregoingapparatuses, the suture is passed through at least one opening in boththe first button and the second button.

In a further non-limiting embodiment of any of the foregoingapparatuses, the suture is arranged to include at least four strandsextending between the first button and the second button.

In a further non-limiting embodiment of any of the foregoingapparatuses, the suture includes a second free end, and the first freeend and the second free end extend through the second button.

In a further non-limiting embodiment of any of the foregoingapparatuses, the first free end and the second free end are tiedtogether in a knot over the second button.

In a further non-limiting embodiment of any of the foregoingapparatuses, in use, the first button is adapted to rest against amedial cortex of a tibia and the second button is adapted to restagainst a lateral cortex of a fibula.

In a further non-limiting embodiment of any of the foregoingapparatuses, a pull-through device is connected to the first button by asecond suture.

A method of ankle syndesmosis repair according to another exemplaryaspect of the present disclosure includes, inter alia, drilling a holethrough a fibula and a tibia, passing a first button through the holeuntil the first button exits on a medial side of the tibia, flipping thefirst button so it rests against a medial cortex of the tibia,approximating a second button to a lateral side of the fibula byapplying traction to a suture that extends between the first button anda second button, and tying a knot in free ends of the suture to securethe second button against a lateral cortex of the fibula.

In a further non-limiting embodiment of the foregoing method, passingthe first button includes connecting the first button to a pull-throughdevice with a pull-through suture, and inserting the suture passingdevice through the hole to advance the first button device horizontallythrough the hole.

In a further non-limiting embodiment of either of the foregoing methods,flipping the first button includes applying traction to the pull-throughsuture while applying counter-traction to the suture until the firstbutton device pivots from a position generally parallel to the hole to aposition generally transverse to the hole.

In a further non-limiting embodiment of any of the foregoing methods,the method includes removing the pull-through suture after flipping thefirst button.

In a further non-limiting embodiment of any of the foregoing methods,the suture is double looped through the first button and the secondbutton.

In a further non-limiting embodiment of any of the foregoing methods,applying the traction to the suture includes applying traction to thefree ends of the suture, the free ends extending through the secondbutton.

In a further non-limiting embodiment of any of the foregoing methods,the method includes visualizing movement of the first button using animage intensifier as the first button is passed through the hole.

In a further non-limiting embodiment of any of the foregoing methods,the method includes visualizing flipping of the first button using theimage intensifier.

In a further non-limiting embodiment of any of the foregoing methods,drilling the hole includes drilling through the fibula with a drill bit,and drilling through the tibia using the same drill bit.

In a further non-limiting embodiment of any of the foregoing methods,the method includes visualizing the drill bit during the drilling usingan image intensifier.

These and other features and advantages of the present invention willbecome apparent from the following description of the invention that isprovided in connection with the accompanying drawings and illustratedembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The apparatuses, methods and buttons of the present invention areillustrated with respect to the following drawings:

FIG. 1 shows a perspective view of a button of the present invention;

FIG. 2 shows a perspective view of the kit of parts comprising anapparatus of the present invention;

FIGS. 3-7 illustrate, in sequence, the steps of a method according tothe second aspect of the present invention;

FIG. 8 shows the mean diastasis in millimetres above the baseline withincreasing intraosseous membrane (IOM) division with no fixation and a 5kg (12.5 Nm) load, in which the error bars represent standard deviationand the use of ** indicates p<0.001;

FIG. 9 shows the apparatus, method and button of the present invention,when compared with A.O. screw fixation at 2 cm with increasing torqueload following total IOM division and, again, the error bars representstandard deviation;

FIGS. 10 and 10 a show an anterior view and a schematic view,respectively, of a normal acromioclavicular joint;

FIGS. 11 and 11 a show an anterior view and a schematic view,respectively, of a Rockwood Type III acromioclavicular jointdislocation, with superior migration of the clavicle with respect to theacromium;

FIG. 12 shows a plan view of a first or second suture anchor in the formof a button of the present invention;

FIG. 13 shows perspective, plan and sectional view of an alternativeembodiment of a button according to the invention;

FIGS. 14 and 14 a show a plan and an undersurface view, respectively, ofa first or second suture anchor in the form of a washer of the presentinvention;

FIG. 14 b illustrates the mobile positioning of the washer against anarcuate undersurface of the screw-head of a bone anchor;

FIG. 15 shows a perspective view of the kit of parts comprising anapparatus of the present invention; and

FIGS. 16 a-16 f illustrate, in sequence, the steps of a method accordingto the present invention.

DETAILED DESCRIPTION

The present invention provides minimally invasive, flexible fixation ofthe ankle syndesmosis whilst resisting tibio-fibular diastasis. Itallows physiological micromotion at the ankle syndesmosis. There is noneed for routine removal of the implant and its use should enablepatients to weight-bear at an earlier stage.

The present invention is indicated for use in the fixation of anklesyndesmosis tibio-fibular diastasis (splaying apart). These aretypically seen in Weber C-type ankle injuries, caused by severepronation-external rotation forces. The fibula is fractured above thelevel of the syndesmosis. A medial ankle injury (malleolar fracture ordeltoid ligament rupture) is also usually present. Reduction andfixation of the ankle syndesmosis is necessary to prevent lateral talarshift, which can lead to premature ankle osteo-arthritis.

Thus, referring to the accompanying drawings, the apparatus of thepresent invention comprises a pair of buttons 10, which, in thepreferred embodiment illustrated are 9 mm by 3.5 mm in dimension, moreparticularly in length and width respectively. The buttons 10 arepreferably formed from titanium or stainless steel, although it will ofcourse be appreciated that any other suitable material could be used, inparticular any suitable bioabsorbable material. The pair of buttons 10each have a first aperture 12 and a second aperture 14 which, in thepreferred embodiment illustrated, are triangular in shape, each of thefirst and second apertures 12, 14 having an apex 16, the respectiveapices 16 preferably being directed away from one another and beinglocated substantially about a longitudinal mid-line of the button 10.Referring in particular to FIG. 2, the pair of buttons 10 are secured orpre-threaded together by means of a flexible coupling in the form offirst suture 18, preferably of no. 5 braided polyester, which is doublelooped through the first and second apertures 12, 14 of the pair ofbuttons 10, as will be described in greater detail hereunder. It will bereadily understood however that any suitable material could be used forthe first suture 18. A straight needle 22 with a second (pull-through)suture 20, again of any suitable material, is also looped through eitherthe first or second aperture 12, 14 of one of the pair of buttons 10,hereinafter referred to as the leading (or first) button 10. The needle22 is preferably 100 mm in length. In the embodiment illustrated in FIG.2, the second suture 20 is looped through the first aperture 12 of thefirst button 10.

TABLE 1 Apparatus/Button of the Present Invention Button 10 overalldimensions: 9.0 mm (length) × 3.5 mm (width) × 1.5 mm (thickness) Basicshape: Oblong in plan shape, with chamfered or rounded corners andedges - this reduces the chance of the button 10 being palpated underthe skin and, in addition, eases the passage of the first button 10through a drill hole 30 as will be explained hereinafter. Button 10material: Preferably titanium or stainless steel Button apertures 12,14: 2 apertures 12, 14 (triangular in plan shape) Aperture 12, 14dimensions: 2 mm base × 2 mm perpendicular height (equilateral trianglewith chamfered corners), 1 mm distance between first and secondapertures Syndesmosis suture 18 Number 5 braided polyethylene suture,(first suture): looped twice through the first and second apertures 12,14 of the first and second buttons 10, leaving the two free ends ofsuture 18 free for tying. Pull-through needle 22: 100 mm long straightneedle 22 with pull- through (or second) suture 20 attached.Pull-through suture 20: Minimum 0-strength suture 20 looped through theaperture 12 of the first button 10, the second suture 20 being securedto the needle 22.

In the present embodiment, leading and trailing edges of the button 10of the present invention are substantially symmetrical, although it willbe appreciated that this is not a requirement of the present invention.Specifically, the leading edge 24 of the button 10 of the presentinvention should be blunt and should have a width sufficient to reducethe possibility that the leading edge 24 of the first button 10 followsthe second or pull through suture 20 through the intact medial skin orto catch or skewer any soft tissue structures between the bone and themedial skin, as will be described in detail hereinafter.

The button 10 of the third aspect of the present invention may beprovided with apertures 12, 14 which are countersunk (not illustrated)so as to allow easier threading passage of the first and second sutures18, 20. Care needs to be taken in such countersinking, to avoidcompromising the mechanical strength of the first and second apertures12, 14 of the button 10 of the present invention.

The first suture 18 used in the apparatus of the present invention canbe of any material, which is suitable for this purpose, whetherabsorbable or non-absorbable, provided it is sufficiently strong. Anumber 5—strength braided polyester (ETHIBOND—Trade Mark) suture ispreferred. This is a non-absorbable suture which knots easily withoutslipping.

The second suture 20 used in the present invention can be of anymaterial which is suitable for this purpose, provided it is of at least0—strength.

The pull through needle 22 can be of any dimensions, provided it is longenough to span the ankle. Its tip can be either “taper cut” or“cutting”.

Set-Up

The patient is positioned supine on a radiolucent operating table (notshown). Intra-operative fluoroscopy is necessary during the procedure.The patient and all theatre personnel should be adequately protected forx-ray radiation. A sandbag (not shown) is placed under the ipsilateralbuttock to facilitate internal rotation of the leg. Antibioticprophylaxis and the use of a tourniquet are recommended.

Instrumentation

An A.O. small fragment set (or equivalent) should be used for fractureosteosynthesis. The 3.5 mm drill bit is required for drilling the hole30 through both the fibula 26 and tibia 28, for the first button 10 andfirst and second sutures 18, 20 to pass through, as illustrated in FIGS.3 to 7. This corresponds to the 3.5 mm drill bit which is part of thesmall fragment set routinely used to internally fix ankle fractures. Itwill, of course, be appreciated that the diameter of the hole 30 must besufficient to permit the first button 10 to be pulled, lengthways,therethrough.

Fracture Fixation

Osteosynthesis should be undertaken according to A.O. principles ofinternal fixation. It is recommended that fractures (not shown) in thelower half of the fibula 26 should be fixed. High fibular fractures(Maisonneuve injury) can be managed by addressing the syndesmosisdiastasis only. Care should be taken not to injure the superficialperoneal nerve during the lateral approach to the fibula 26; the nervepasses posteriorly to anteriorly as it pierces the deep fascia. Aone-third tubular plate usually provides sufficient stability and can becontoured easily to sit on the bone. The use of a lag screw for fracturecompression is rarely required, once fibular length and rotation havebeen corrected.

Syndesmosis Reduction

The syndesmosis is reduced by internal rotation of the ankle, at around30° of plantar flexion. This does not result in an over-tightening ofthe syndesmosis. Reduction should be confirmed using the imageintensifier.

Drilling

All four cortices are drilled from the open lateral side using the 3.5mm drill bit. The drill (not shown) should be angled at 30° upwards fromthe horizontal, at a distance of 2-3 cm above the ankle joint. Placing afinger on the medial aspect of the leg can help with aiming and feelwhen the drill has passed through. The drill hole 30 may go through oneof the holes of a one-third tubular plate (not shown), if needed. Toensure accurate placement, drilling should be performed under imageintensifier control.

Button Placement

The long straight needle 22 with pull-through, second suture 20 ispassed through the drill-hole 30 and out the intact medial skin (seeFIG. 3). The pull-through suture 20, which engages the apex 16 of thefirst aperture 12 of the first button 10, can now advance the first orleading button 10, substantially horizontally through the drill hole 30(FIGS. 4 & 5). Engagement of the second suture 20 in the apex 16 ensuresthat the second suture 20 is located adjacent the longitudinal mid-lineof the first button 10 so that the second suture 20 stays central in thefirst aperture 12. Once this first button 10 has exited the medial tibia28, the angle of traction on the pull-through, or second suture 20 ischanged and counter-traction is exerted on the first suture 18, in orderto flip (pivot) and engage the first button 10 against the medial tibialcortex (FIG. 6). Once the first button 10 is anchored, the pull-through(second) suture 20 can be cut and removed. The trailing or second button10 is tightened down on the lateral side by further traction on the freeends of the first suture 18 and should be tied hand tight (FIG. 7). Thiswill further squeeze the syndesmosis but will not over-tighten it.

Post-Operative Management

Following wound closure, the ankle should be placed in either awell-padded below-knee cast or backslab, ensuring the ankle is kept in aneutral position. The patient should be kept non-weight bearing for thefirst two weeks, and then allowed to partial weight-bear (50%) from twoto six weeks in cast, depending on fracture stability. Full weightbearing can be allowed out of cast at six weeks.

Implant Removal

Routine removal of the suture-button construct is not required. If, forany reason, it needs to be removed, this can be performed simply bysmall incisions over the medial and lateral buttons 10, cutting thefirst suture 18 as it loops through the button 10 and removing the pairof buttons 10 and the first suture 18.

Example 1

Phase One aims to reproduce a cadaver model of a syndesmosis injury,with a medial deltoid ligament rupture. An intact fibula simulates ananatomically fixed fracture. Phase two compares the suture-button versusconventional A.O. screw fixation following total intraosseous membrane(IOM) division, in a model resembling a Maisonneuve injury.

Material and Methods

Sixteen embalmed cadaver legs (eight pairs) were used. For each leg (notshown), the tibia and foot were fixed to a customised jig using Steinmanpins. The foot was fixed to a mobile footplate so that the centre ofrotation was directly under the centre of the ankle joint. Externalrotation moment was applied tangential to the centre of rotation at aradius of 25 cm. 1 kg of weight used therefore corresponds toapproximately 2.5 Newton-meters of torque. The syndesmosis was exposedvia an antero-lateral approach. Marker pins were placed in the tibia andfibula at the level of the syndesmosis to aid clinical and radiographicmeasurements. Clinical measurements were made using vernier calipers. Inorder to reduce bias, x-rays received a coded label to help blindsubsequent review. The distance between the tips of the marker pins wasmeasured on the mortise view x-ray. The stress lateral view was found tobe less reliable, due to lack of reproducibility.

A 5 kg (12.5 Nm) load was used for all phase one measurements. Followingbaseline readings, the medial deltoid and syndesmotic ligaments weredivided. Measurements of diastasis were taken following 5 cm, 10 cm andtotal intraosseous membrane division.

In phase two, left and right ankles were randomised to receive asuture-button 10 (4 mm×11 mm; the button being a conventional buttonmarketed by Smith & Nephew Inc. under Endo-Button®) or A.O. standard(4.5 mm) screw fixation (not shown). In both groups, the syndesmosis wasfirst reduced by internal rotation of the footplate. A hole was thendrilled from lateral to medial, at 30° anterior to the horizontal, 2 cmsuperior to the ankle joint.

In the suture-button group of the present invention, a 4 mm drill hole30 was drilled through all four cortices. The no. 5 braided polyesterfirst suture 18 was looped twice through first and second apertures 12,14 of the first and second buttons 10. The second suture 20 was threadedthrough the first aperture 12 of the first button 10 and also throughthe needle 22. This needle 22 was passed into the drill hole 30 from thelateral side and out through the intact medial skin. Using the leadingpull-through suture 20, the first button 10 was advanced horizontallyalong the drill hole 30 until it has exited the medial tibial cortex.Using the leading pull-through second suture 20, whilst maintainingtraction on the braided polyester first suture 18, the first button 10was flipped to engage and anchor against the medial tibial cortex. Thesecond suture 20 was then pulled out. The second button 10 was tightenedagainst the lateral fibular cortex by further manual traction on thebraided polyester first suture 18. The first suture 18 was securely tiedover the second button 10 when flush with the lateral fibular cortex.The progress of the first button 10 may be followed intra-operativelyusing an x-ray image intensifier (not shown), if available.

In the comparative group (A.O. screw), a 3.2 mm drill hole was drilledthrough all four cortices. The hole was measured, tapped and an A.O. 4.5mm cortical screw inserted to engage all four cortices, maintaining thereduction of the syndesmosis, without compression.

Measurements of syndesmosis diastasis were taken both under directvision and radiographically at increasing external rotation torques.Torque loads were increased in increments of 1 kg, to a maximum of 8 kgor until fracture or implant failure. In four ankles (two per group),fixations were also tested at 5 cm above the ankle joint, having removedthe fixations at 2 cm, in order to determine the optimum level offixation placement.

Results

In phase one, the mean values of the measured diastasis above thebaseline value at 5 cm, 10 cm and total intraosseous (IOM) divisionunder 5 kg (12.5 Nm) load were 3.7 mm, 5.5 mm and 7.2 mm, respectively(see FIG. 8). Each value showed significant increase in diastasiscompared to the previous measurement, (p<0.001, unpaired t-test).Radiographic measurements were less reliable than direct clinicalmeasurements, but gave a similar picture.

In phase two, there was a gradual diastasis with increasing torque loadin both groups, which was probably due to the quality of the bone. Themean diastasis from baseline for the suture-Endo-Button® and the A.O.screw groups for torque loads increasing at 1 kg intervals, up to 8 kg,are shown in Table 2. These differences were not statisticallysignificant (p=0.7, unpaired t-test, FIG. 9).

The apparatus and method of the present invention did give a moreconsistent performance, though. The distribution of standard deviationsfor A.O. screw fixation was 0.64 mm higher than that for the apparatusand method of the present invention (95% C.I. 0.46 to 0.84,Hodges-Lehmann estimation of shift).

There were no implant failures in either group. There were two fibularfractures in the A.O. screw group, prior to reaching the 8 kg load (5kg, 8 kg). Only measurements prior to fracture were used for analysis.By comparison, there was one fibular fracture in the group of thepresent invention (8 kg). Comparing fixation placement at 2 cm versus 5cm showed no significant difference (Table 2).

Discussion

The cadaver model in this study was tested using a jig (not shown)generating external rotation torque, which reproduces the mechanism ofsyndesmosis injury and, therefore, reflects the clinical situation.

Syndesmosis diastasis is seen with increasing intraosseous membranedivision, under an external rotation torque load. This corroborates thefindings of previous studies, showing a significantly larger diastasiswith greater intraosseous membrane division.

Regarding the level of placement of the fixation, there was a trendtowards better fixation at 2 cm, although only a small sample size wastested (Table 2).

Flexible fixation gives a more physiological end-result, allowing formicromotion at the distal tibio-fibular joint. Implant fatigue orbreakage is less likely and routine removal is not essential. Thisavoids the complication of loss of reduction following removal offixation. Earlier weight-bearing may be allowed, depending on theoverall fracture configuration.

The advantages of the suture-button technique are that it is simple,flexible, minimally invasive as the medial side does not need to beopened, and has given a consistent performance on biomechanical testing.Clinical testing of the suture-button in ankle injuries that requirereduction and fixation of a syndesmosis diastasis is recommended.

TABLE 2 Mean diastasis in millimetres above baseline post-fixation,under increasing torque load. 1 kg is equivalent to 2.5 Nm of torque.(Standard deviations are in parentheses.) Button A.O. Screw Button A.O.Screw [2 cm] n = 8 [2 cm] n = 8 [5 cm] n = 2 [5 cm] n = 2 1 kg 1.0 mm(0.41) 1.3 mm (0.58) 2.5 mm 2.0 mm 2 kg 2.0 mm (0.00) 2.5 mm (0.87) 3.0mm 3.0 mm 3 kg 2.8 mm (0.29) 3.2 mm (1.04) 3.5 mm 4.0 mm 4 kg 3.6 mm(0.48) 3.8 mm (1.25) 4.0 mm 5.0 mm 5 kg 4.2 mm (0.57) 4.3 mm (1.30) 5.0mm 5.5 mm 6 kg 4.9 mm (0.53) 5.3 mm (1.04) 6.0 mm 6.0 mm 7 kg 5.4 mm(0.53) 5.7 mm (1.25) 6.5 mm 7.0 mm 8 kg 5.9 mm (0.53) 6.8 mm (1.05) 7.0mm 8.0 mm

Example 2

Patients with Weber C ankle fractures who had suture-button fixation,were compound with a cohort of patients who had syndesmosis screwfixation.

Methods

8 patients had suture-button fixation. The buttons used in Example 2were conventional buttons supplied by Smith & Nephew Inc. and marketedunder Endo-Button®. A retrospective cohort of 8 patients with similarWeber C fractures, treated using syndesmosis screw fixation, wererecalled for clinical and radiological evaluation. Outcome was assessedusing the American Orthopaedic Foot and Ankle Surgeons (AOFAS) score ona 100-point scale.

Results

Patients with screw fixation had a mean AOFAS score of 79 (range:61-100) at an average follow-up of four months (range: 3-6 months). Thesuture-button group had a mean score of 92 (range: 76-100) atthree-month review (p=0.02, unpaired t-test). Six of the screw grouprequired further surgery for implant removal, compared to none of thesuture-button group (p=0.007, Fisher's exact test).

Conclusion

Patients treated using the suture-button 10 regained a better functionaloutcome, within a shorter time frame. The technique is minimallyinvasive, as the medial side is not opened, and allows tibio-fibularmicromotion whilst resisting diastasis. The need for secondary surgeryfor implant removal is significantly lessened. The suture-buttontechnique may become the gold standard for syndesmosis diastasisinjuries.

The present invention also provides minimally invasive, flexiblefixation of the AC joint dislocation by resisting superior migration ofthe clavicle with respect to the coracoid process. It allowsphysiological micromotion at the AC joint. There should be no need forroutine removal of the implant.

The present invention is indicated for use in the fixation of AC jointdislocation. These are typically seen in Rockwood type III AC jointdislocations, usually caused by severe downward blunt trauma to thepoint of the shoulder, or acromium. Typically, the clavicle is upwardlydisplaced as a result of the injury because of disruption to the AC andcoracoclavicular ligaments. Reduction and fixation of displaced AC jointdislocations are necessary to prevent painful deformity and loss offunction.

FIGS. 10 and 10 a show anterior and schematic views of a normal shoulder10. FIGS. 11 and 11 a show anterior and schematic views of a shoulder 10that has suffered a Rockwood type III AC joint dislocation injury.

Referring to FIGS. 10 and 11, the structure of a shoulder 10 relevant toa Rockwood type III dislocation injury includes the clavicle 12, thecoracoid process 14 and the acromium 16. The acromium 16 and theclavicle 12 are connected by the acromioclavicular ligament 18. Theacromioclavicular ligament 18 extends from the lateral end 20 of theclavicle 12 to the medial surface 22 of the acromium 16. The coracoidprocess 14 is connected to the clavicle 12 by the coracoclavicularligaments 24, which comprise the trapezoid ligament 26 and the conoidligament 28. The coracoclavicular ligaments 24 extend from the inferiorsurface 30 of the clavicle 12 to the superior surface 32 of the coracoidprocess 14.

A Rockwood type III AC joint dislocation is characterized by thedisruption of the AC and the coracoclavicular ligaments 18, 24,respectively. As shown in FIGS. 11 and 11 a, the clavicle 12 separatesfrom, and moves away from, the coracoid process 14 and the acromium 16,accompanied by disruption of the coracoclavicular and the AC ligaments18, 24, respectively. The acromioclavicular joint 34 (FIG. 11) isdislocated and the clavicle 12 is relatively displaced upwardly. Thecoraco-acromial ligament 36 (FIG. 10) is not impacted in the type IIIshoulder dislocation.

Repair of the type III shoulder dislocation according to the presentinvention is an out-patient procedure performed with a generalanesthetic. The procedure is done with the patient lying supine on theoperating table, preferably in the “deck-chair” position to allow thesurgeon full access to the affected shoulder.

Referring to FIG. 12, the apparatus of the present invention comprises afirst or second suture anchor in the form of a button 50, which, in theembodiment illustrated, is about 10.0 mm in length by about 3.5 mm inwidth. The button 50 is preferably formed from titanium or stainlesssteel, although it will be appreciated that any other suitable materialcould be used, in particular any suitable bioabsorbable material. Thebutton 50 has a first aperture 52 and a second aperture 54 which, in theembodiment illustrated, are oblong in shape, the longitudinal mid-lineof each of the first and second apertures 52, 54 being locatedsubstantially about a longitudinal mid-line of the button 50.

Referring to FIG. 13, there is illustrated an alternative first orsecond suture anchor, generally indicated as 150. In the illustratedalternative embodiment, the button 150 is about 9.0 mm in length byabout 3.5 mm in width, with a thickness of about 1.5 mm. The button 150has first and second apertures 152 and 154, respectively. In theillustrated alternative embodiment, each of the apertures 152, 154 aretriangular in shape, the respective apices 155 being directed away fromeach other and being located substantially about a longitudinal mid-lineof the button 150.

Reference is now made to FIGS. 14 and 14 a which illustrate a first orsecond suture anchor in the form of a washer 60. In the illustratedembodiment, the washer 60 has an external diameter of about 10.0 mm.While the illustrated washer is disc-shaped, the washer is not solimited. The washer 60 is preferably formed from titanium or stainlesssteel although, as will be appreciated by those skilled in the art, anyother suitable material, in particular any suitable bioabsorbablematerials, may be used. The washer 62 also has at least two flexiblecoupling-locating apertures 64. In the illustrated embodiment, there arefour apertures 64 circumferentially arranged about the aperture 62. Inthe illustrated embodiment, each of the apertures 64 has a diameter ofabout 1.0 mm Each of the apertures 64 have beveled edges, above andbelow, while the aperture 62 has beveled edges above.

The washer 60 also has a substantially centrally located bonescrew-retaining aperture 62. In the illustrated embodiment, the aperture62 has a diameter of about 4.6 mm and the washer 60 is adapted to allowmobile positioning against an arcuate undersurface 69 of the head of thebone screw 68 (illustrated in FIG. 14 b).

Referring to FIGS. 14 and 14 a, the washer 60 of the fourth aspect ofthe present invention is provided with a screw-retaining aperture 62 andat least two flexible coupling-locating apertures 64 which arepreferably countersunk so as to allow easier threading passage of theflexible coupling 70 (not shown in FIGS. 14-14 b). Care needs to betaken in such countersinking, to avoid compromising the mechanicalstrength of the apertures 62, 64 of the washer 60.

FIG. 15 illustrates the implant apparatus used for fixation of the ACjoint dislocation. The button 50 and the washer 60 are secured orpre-threaded together by means of a flexible coupling in the form offirst suture 70, preferably of number 5-strength braided polyester,which is double looped through the first and second apertures 52, 54 ofthe button 50 and the peripheral apertures 64 of the washer 60, as willnow be described in greater detail. Specifically, the first suture 70 isfed through to aperture 64 a of the washer 60; through the second andfirst apertures 54, 52 of the button 50; through the aperture 64 b,under the washer 60 and back out the aperture 64 c; through the secondand first apertures 54, 52 of the button 50 again; and finally throughthe aperture 64 d of the washer 60. A needle 72, which may be straightor curved, with a second, pull-through suture 74 is also looped througheither the first or second apertures 52, 54 of the button 50. The secondsuture 74 is looped through the first aperture 52 of the button 50.

The first suture 70 used in the apparatus can be made from any materialwhich is suitable for this purpose, whether absorbable ornon-absorbable, provided it is sufficiently strong. A number 5-strengthbraided polyester (FIBERWIRE®) suture is preferred. This is anon-absorbable suture which knots easily without slipping. The secondsuture 74 can be made from any material which is suitable for thispurpose, and preferably should be at least 0-strength.

The pull through needle 72 can be of any dimensions, provided it is longenough to span the clavicle 12 or the coracoid process 14 of theshoulder 10. The needle 72 is preferably about 100 mm in length. Theneedle's body can either be straight or curved. The needle's tip can beeither “taper cut” or “cutting.”

In the present embodiment, leading and trailing edges of the button 50are substantially symmetrical, although it will be appreciated that thisis not a requirement of the present invention. Specifically, the leadingedge 56 (illustrated in FIG. 15) of the button 50 should be blunt andshould have a width sufficient to reduce the possibility that theleading edge 56 of the button 50 follows the second or pull-throughsuture 74 through the intact skin or to catch or skewer any soft tissuestructures between the bone and the skin, as will be described in detailhereinafter.

FIG. 15 also illustrates a bone screw 68 as part of the implantapparatus. The bone screw 68 is used for engaging the washer 60 with thecoracoid process 14 (FIG. 16 f). As discussed below in detail and withreference to FIG. 14b , the bone screw 68 has an arcuate undersurface 69for defining the movement of the washer 60 between the coracoid process14 and the arcuate undersurface 69.

TABLE 3 Apparatus/Button of FIGS. 12 and 15 Button 50 overalldimensions: 10.0 mm (length) × 3.5 mm (width) × 1.5 mm (thickness) Basicshape: Oblong in plan shape, with chamfered or rounded corners andedges - this reduces the chance of the button 10 being palpated underthe skin and, in addition, eases the passage of the button 50 through adrill hole as will be explained hereinafter. Button 50 material:Preferable titanium or stainless steel Button apertures 52, 54: Twoapertures 52, 54 (oblong in plan shape) Aperture 52, 54 dimensions: 2 mmheight × 3 mm length (oblong with chamfered edges), preferably 1 mmdistance between first and second apertures Suture 70 (first suture):Number 5 strength braided polyester suture, looped twice through thefirst and second apertures 52, 54 of the button 50 and each of the fourapertures 64 (64a, 64b, 64c, 64d) of the washer, leaving the two freeends of suture 70 free for tying adjacent the undersurface of the washer60. Pull-through needle 72: 100 mm long straight, or curved, needle 72with pull-through, or second suture 74 attached. Pull-through suture 74:Minimum 0-strength suture 74 looped through the aperture 52 of thebutton 50, the second suture 74 being secured to the needle 72.

The following sets out the procedure, as shown in FIGS. 16 a-16 f, to befollowed for Rockwood Type III dislocations. Surgeons skilled in the artwill appreciate the modifications that might be needed in addressingRockwood Type II and IV-VI dislocations.

Set-Up

The patient is positioned in a “deck-chair” position on the operatingtable (not shown). A sandbag (not shown) can be placed under the scapulato ease access to the shoulder region. A longitudinal or horizontalincision of about 5 cm is made on the skin, at the front of theshoulder, overlying the coracoid process 14 and the clavicle 12. Theclavicle 12 and the superior surface of the coracoid process 14 areexposed by blunt dissection. As explained in detail below, if theclavicle hole 80 is to be drilled (FIG. 16a ) from above andsubstantially downwardly through the clavicle 12, it will also benecessary to retract the skin about the clavicle 12, in order to exposethe superior surface 33 of the clavicle 12.

Instrumentation

A 3.5 mm drill bit is required for drilling a hole 80 through theclavicle 12. A 2.5 mm drill bit is required for drilling a hole 82 intothe base of the coracoid process 14 of the scapula (FIG. 16 a). It isnot necessary that the drill holes 80, 82 be aligned with each other. Inaddition, it is not necessary, when the coracoclavicular interspace isreduced to normal, that the longitudinal axes of the respective drillholes 80, 82 be co-linear or even substantially parallel with eachother.

Button Placement

As illustrated in FIG. 16b , the long straight needle 72 withpull-through, second suture 74 is passed upwards through the 3.5 mmdrill hole 80 in the clavicle 12 and can be passed through the intactskin on the superior aspect of the clavicle 12 or through the opensurgical wound. In FIG. 16 c, the pull-through suture 74, which engagesthe first aperture 52 (not shown) of the button 50, can now advance thebutton 50, substantially longitudinally through the drill hole 80.Engagement of the second suture 74 in the aperture 52 (not shown)ensures that the second suture 74 is located adjacent the longitudinalmid-line of the button 50 so that the second suture 74 stays central inthe first aperture 52.

In FIG. 16d , once the button 50 has exited the superior surface 33 ofthe clavicle 12, the angle of traction on the pull-through, or second,suture 74 is changed and counter-traction is exerted on the first suture70, in order to flip (pivot) the button 50 and engage the button 50against the superior surface 33 of the clavicle 12. Once the button 50is anchored, the pull-through, or second, suture 74 can be cut andremoved (FIGS. 16d and 16e ). In FIG. 16 f, the screw 68 containing thewasher 60 is inserted into the 2.5 mm drill hole 82 (FIG. 16e ) in thebase of the coracoid process 14 of the scapula. Before the washer60/bone screw 68 is fully seated into the drill hole 82, theacromioclavicular joint 34 is reduced by downward manual pressure on thelateral end 20 of the clavicle 12 (FIGS. 16e and 16f ).

The two trailing ends of the first suture 70 (FIG. 16e ) are pulled toapproximate the desired distance between the button 50 and the washer60, and hence reduce the interval between the clavicle 12 and thecoracoid process 14. The first suture 70 is then secured to itself witha knot, tied tight by hand. The free ends of the first suture 70 canthen be cut approximately 1 cm long, to avoid knot slippage. The screw68 can then be fully seated into the drill hole 82 in the coracoidprocess 14 to maximize suture tension, or may be advanced or retractedaccordingly to fine tune the suture tension, according to the surgeon'spreference.

The volume between the arcuate undersurface 69 of the bone screw 68 andthe coracoid process 14 defines the maximum flexibility of the washer 60therebetween. The designed flexibility is helpful in increasing thetolerance for non-aligned drill holes and the like.

Post-Operative Management

Following wound closure, the shoulder should be placed in a shoulderimmobilizer for three weeks. Gentle range of motion exercises can beginafter three weeks. Full range exercises can be allowed after six weeks.

Implant Removal

Routine removal of the first suture anchor-suture-second suture anchorconstruct is not required. If, for any reason, it needs to be removed,this can be performed simply by re-opening the surgical incision,cutting the first suture 70 as it loops through the button 50 andremoving the button 50. The screw 68 and washer 60 can be removed easilyusing the screwdriver.

It is noted that the above description and drawings are exemplary andillustrate preferred embodiments that achieve the objects, features andadvantages of the present invention. It is not intended that the presentinvention be limited to the illustrated embodiments. Any modification ofthe present invention which comes within the spirit and scope of thefollowing claims should be considered part of the present invention.

What is claimed is:
 1. A method of ankle syndesmosis repair, comprising:drilling a hole through a fibula and a tibia with a drill bit; pulling afirst suture fixation device through the hole with a pull-through sutureuntil the first suture fixation device exits at a medial side of thetibia; flipping the first suture fixation device to a resting positionrelative to the tibia; and positioning a second suture fixation deviceat a lateral side of the fibula, wherein a flexible suture coupling isconnected to the first suture fixation device and the second suturefixation device.
 2. The method as recited in claim 1, comprisingreducing a fracture of the fibula prior to drilling the hole.
 3. Themethod as recited in claim 1, wherein pulling the first suture fixationdevice includes: connecting the first suture fixation device to a suturepassing instrument with the pull-through suture; and inserting thesuture passing instrument through the hole to advance the first suturefixation device horizontally through the hole.
 4. The method as recitedin claim 3, wherein flipping the first suture fixation device includes:applying traction to the pull-through suture while applyingcounter-traction to the flexible suture coupling until the first suturefixation device pivots from a position generally parallel to the hole tothe resting position, wherein, in the resting position, the first suturefixation device is generally transverse to the hole.
 5. The method asrecited in claim 1, wherein the flexible suture coupling is doublelooped through the first suture fixation device and the second suturefixation device.
 6. The method as recited in claim 1, whereinpositioning the second suture fixation device includes: applyingtraction to a free end of the flexible suture coupling until the secondsuture fixation device is tightened down at the lateral side of thefibula.
 7. The method as recited in claim 1, wherein the first suturefixation device and the second suture fixation device each include atleast one aperture.
 8. The method as recited in claim 1, wherein pullingthe first suture fixation device includes: passing an elongatedpull-through device that is connected to the pull-through suture throughthe hole.
 9. The method as recited in claim 1, comprising reducing asyndesmosis disruption prior to performing the drilling, the pulling,the flipping and the positioning.
 10. The method as recited in claim 1,wherein the first suture fixation device includes an elongated shape,and the second suture fixation device includes a shape that is differentfrom the elongated shape.
 11. The method as recited in claim 1, whereinthe drill bit is drilled through both the fibula and the tibia duringthe drilling.
 12. The method as recited in claim 1, wherein pulling thefirst suture fixation device includes: pulling the first suture fixationdevice in a lateral-to-medial direction.
 13. The method as recited inclaim 1, wherein flipping the first suture fixation device includes:pivoting the first suture fixation device until the first suturefixation device rests over a medial cortex of the tibia.
 14. The methodas recited in claim 1, wherein the first suture fixation device includesa button.
 15. The method as recited in claim 1, wherein at least aportion of the second suture fixation device is round, and wherein afree end of the flexible suture coupling passes through an apertureformed through the portion of the second suture fixation device that isround.